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The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for:
• balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purpose of improving myocardial perfusion
The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.5-4.0mm configurations) is indicated for:
• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
• balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
The Sapphire® II PRO Balloon Dilatation Catheter is also indicated for:
• percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

The Sapphire II PRO Balloon Dilatation Catheter is now also available as an over-the-wire balloon catheter with a working length of 150cm. The semi-compliant balloons are available in diameters from 1.0-1.25mm and lengths from 5-15mm with a rated burst pressure of 14 atmospheres. The catheter consists of proximal section with a Y-type hub and distal section with a balloon near the distal tip. The straight port of the hub is the guidewire entrance and the side port is used to inflate and deflate the balloon. The external lumen provides for inflation of the balloon with dilute contrast media solution. The internal lumen permits the use of a standard 0.014 inch guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. Hydrophilic lubricious coatings are applied to the distal section. One radiopaque platinum marker band is located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters and 4F or larger guiding sheaths. Two marked sections (3mm in length) are located on the proximal shaft to indicate catheter position relative to the tip of either guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided document is a 510(k) summary for the Sapphire II PRO Balloon Dilatation Catheter. It outlines the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to a predicate device.

However, the document does not contain the specific type of acceptance criteria and study detailed in the request, which typically pertains to the performance evaluation of a diagnostic or AI-driven medical device (e.g., accuracy, sensitivity, specificity, human reader study data). This document describes performance testing for a physical medical device (balloon catheter), focusing on mechanical properties, sterilization, and biocompatibility.

Therefore, I cannot extract the information to fill out the requested table and answer questions 2-9 from the provided text. The document does not describe a study that proves a diagnostic algorithm meets acceptance criteria.

Based on the provided text, here's what can be inferred about the "acceptance criteria" and "study" for this device, though it doesn't align with the template for diagnostic or AI device evaluation:

• Acceptance Criteria (Implied): The acceptance criteria are related to the physical and functional performance of the balloon dilatation catheter. The statement "The Sapphire II PRO balloon dilatation catheter test results met all acceptance criteria and were similar to the predicate device" implies that the device had to pass certain predefined thresholds for parameters such as:

  • Balloon Rated Burst Pressure
  • Balloon Fatigue
  • Balloon Compliance
  • Catheter Bond Strength
  • Tip Pull Strength
  • Radiopacity
  • Coating Integrity
  • Dimensional Verification
  • Shaft Burst
  • Balloon Inflation and Deflation Time
  • Flexibility and Kinking
  • Torque Strength
  • Particulate Evaluation
  • Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Genotoxicity)
  • Sterilization
  • Visual Inspection
  • Balloon Preparation, Deployment, and Retraction

• Study That Proves the Device Meets Acceptance Criteria: The study described is a series of bench tests and laboratory evaluations to demonstrate the physical, mechanical, and biological compatibility of the Sapphire II PRO Balloon Dilatation Catheter. The primary objective was to show that the new over-the-wire design meets the same performance standards as its predicate device (OrbusNeich Sapphire II PRO, K180921) and other reference devices, and that it is safe and effective for its intended use.

Therefore, the requested table and answers to questions 2-9 cannot be fully provided as the information is not present in the supplied text.

Here is what can be extracted or stated based on the provided document in the context of the user's request, acknowledging the mismatch in the type of device and study:

Table of Acceptance Criteria and Reported Device Performance:

(Note: The table above reiterates that all listed tests for the subject device "met all acceptance criteria and were similar to the predicate device." Specific numerical performance values are not provided in this summary.)

Answers to Specific Questions (based on the provided text's context of a physical device, not a diagnostic/AI device):

1. Sample sizes used for the test set and the data provenance:

   • Sample sizes: Not specified in the provided text. The text only lists the types of tests performed.
   • Data provenance: Not explicitly stated (e.g., country of origin) but implied to be from laboratory testing performed by or for OrbusNeich Medical Trading Inc. The text mentions "Testing was leveraged from the predicate device (K180921) when applicable" and "Additional testing was performed to support the use of the Sapphire II PRO balloon dilatation catheter over-the-wire shaft design," indicating these are laboratory/bench studies, not clinical (retrospective or prospective) patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable (N/A) in this context. This question refers to human assessment for ground truth in diagnostic studies. For a physical device, ground truth established by standard testing methods (e.g., measuring dimensions, burst pressure, biocompatibility assays) does not involve human expert consensus in the same way.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A. This refers to adjudication in human reader studies for diagnostic accuracy.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • N/A. This device is a physical balloon catheter, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is a physical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For a physical device, "ground truth" is established by objective, quantitative measurements and standardized laboratory test results based on engineering specifications and regulatory standards (e.g., ISO, ASTM). For example, the "ground truth" for balloon burst pressure is the measured pressure at which the balloon ruptures, compared against a specified acceptance limit. For biocompatibility, it's the results of verified biological assays.

7. The sample size for the training set:

   • N/A. This device is not an AI model requiring a training set.

8. How the ground truth for the training set was established:

   • N/A. No training set is used for this type of device.

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The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purposes of improving myocardial perfusion. The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. The Sapphire® II PRO balloon dilatation catheter is also indicated for: percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

The Sapphire II PRO balloon dilatation catheter is a rapid exchange balloon catheter with a working length of 140cm design for both coronary and peripheral indications. This catheter was previously cleared for coronary use (K173680, K163114) and this submission is intended to support the peripheral use of this balloon catheter. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.0-4.0mm and lengths from 5-30mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for the Ø1.0-1.5mm configurations). The catheter is compatible with 4F or larger guiding sheaths or 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a guiding sheath or guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sapphire II PRO Balloon Dilatation Catheter, focusing on the peripheral use indication:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table format alongside performance data. Instead, it states that the device "met all acceptance criteria" and "were similar to the reference devices" for the performed tests.

The performance tests conducted include:

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for any of the tests. It refers to testing being "leveraged from the reference device (K173680, K163114)" for many criteria, and "additional testing was performed" for others.

There is no information on the country of origin of the data, and the studies are retrospective in the sense that existing data from previous clearances (K173680, K163114) were used, supplemented by new (implicitly prospective) tests for the peripheral use indication.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This document describes a medical device clearance for a balloon catheter, not an AI/software device. Therefore, the concept of "experts" establishing ground truth in the context of clinical imagery or diagnostic data is not applicable here. The ground truth for device performance is established through engineering and performance testing against predetermined specifications.

4. Adjudication Method for the Test Set

Not applicable for this type of medical device performance testing. Adjudication methods like "2+1" or "3+1" are relevant for expert review of clinical cases, often in AI development contexts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, an MRMC comparative effectiveness study was not done. This is a physical medical device, not an AI system being evaluated for diagnostic or interpretive tasks by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications and established performance standards for balloon dilatation catheters. These standards are likely derived from industry best practices, regulatory guidance, and clinical requirements for the safe and effective operation of such devices. For example, balloon burst pressure needs to meet a certain PSI, and shaft flexibility needs to fall within a defined range.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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The Sapphire II PRO coronary dilatation catheter (1.0-1.25mm configurations) is indicated for: * balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (>70% stenosis) for the purposes of improving myocardial perfusion.

The Ø1.0-1.25mm Sapphire II PRO coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.0-1.25mm and lengths from 5-15mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. One radiopaque platinum marker band is centrally located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The information provided is about the Sapphire II PRO Coronary Dilatation Catheter (1.0-1.25mm configurations). This is a medical device, and the document describes a clinical study to assess its safety and effectiveness.

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a pass/fail format for each criterion. Instead, it describes a primary endpoint for Device Procedural Success and secondary endpoints for effectiveness and safety, along with their observed results. I will construct a table reflecting these key outcomes.

2. Sample size used for the test set and the data provenance

• Sample Size: 61 patients (67 lesions)
• Provenance: Prospective, open-label, multicenter, single-arm, observational study conducted at four (4) US sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document mentions "Angiographic Core Lab" and "Clinical Event Committee (CEC) adjudication" for various endpoints.

• Angiographic Core Lab: Responsible for reporting several secondary peri-procedural endpoints (e.g., vessel perforation, dissection, TIMI flow, MLD). The number and qualifications of experts in this core lab are not specified in the provided text.
• Clinical Event Committee (CEC): Responsible for adjudicating in-hospital clinical safety and efficacy endpoints (e.g., MACE, MI, TLR, TLF, ST). The number and qualifications of experts in the CEC are not specified in the provided text.
• Site Reported and Adjudicated: Some endpoints were site-reported and then adjudicated, implying review by professionals at the study sites, but specific numbers and qualifications are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document states:

• "Site Reported and Adjudicated" for some peri-procedural endpoints.
• "Core Lab Reported" for other peri-procedural endpoints.
• "Clinical Event Committee (CEC) adjudication" for in-hospital clinical safety and efficacy endpoints.

However, the specific adjudication method (e.g., 2+1, 3+1 consensus) used by the Core Lab or CEC is not detailed in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study or AI assistance in this document. This study is a clinical trial for a coronary dilatation catheter, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical medical instrument (a catheter) and not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth was established through a combination of:

• Clinical observation and assessment: By the treating physicians at the study sites, reported as "Site Reported."
• Angiographic Core Lab analysis: Objective assessment of angiograms.
• Clinical Event Committee (CEC) adjudication: Expert review and classification of clinical events.
• Outcomes data: Such as the occurrence of MACE, MI, and TLR.

8. The sample size for the training set

This question is not applicable as the study describes a clinical trial for a physical medical device, not a machine learning model. There is no concept of a "training set" for the device itself in this context.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set for the device.

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The Sapphire II PRO coronary dilatation catheter is indicated for:
• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
• balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

The Sapphire II PRO coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.5-4.0mm and lengths from 10-30mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for the Ø1.5mm configurations). The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text is related to the FDA 510(k) premarket notification for the "Sapphire II PRO Coronary Dilatation Catheter." This document describes the device, its intended use, and indicates that performance tests were conducted. However, it does not contain specific acceptance criteria values or detailed results of a study in the format requested for AI/medical device performance.

The text details the following about the device's testing:

• Performance Data: "Both in vitro performance tests, such as dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, and particulate evaluation, and also biocompatibility tests, such as cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance), pyrogenicity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Sapphire II PRO coronary dilatation catheter."
• Result: "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Sapphire II PRO coronary dilatation catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."

Based on the provided text, I cannot complete the table or provide specific answers to most of the numbered questions because the document lacks the detailed information about acceptance criteria values, specific reported device performance values, sample sizes, ground truth establishment, or any mention of AI or MRMC studies.

The questions posed (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance for AI) are typically relevant for AI/Machine Learning-based medical devices, which is not what the "Sapphire II PRO Coronary Dilatation Catheter" is. This is a physical medical device (a balloon catheter). Therefore, the requested information structure does not directly apply to this type of device and the information is not present in the document.

However, I can extract what is explicitly stated:

• Study Type: The studies conducted were in vitro performance tests and biocompatibility tests. These are standard for physical medical devices and not related to AI.
• Acceptance Criteria Mention: The document states that "The test results met all acceptance criteria," but it does not specify what those criteria are in quantitative terms.
• Ground Truth: For a physical device like a catheter, "ground truth" typically refers to established engineering specifications, material properties, and biological safety standards, rather than expert consensus on diagnostic interpretations or pathology as would be the case for AI. The document implies these were based on "the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."

Therefore, many parts of your request are not applicable or cannot be answered from the given text.

Here's a response based on the absence of the requested AI-specific information and what is available:

The provided document describes the FDA 510(k) premarket notification for the "Sapphire II PRO Coronary Dilatation Catheter," a physical medical device, not an AI or software-as-a-medical-device. As such, many of the requested details, particularly those pertaining to AI model evaluation (e.g., test set sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details), are not applicable to this type of submission and are not present in the document.

The document indicates that various in vitro performance and biocompatibility tests were conducted. It states that "The test results met all acceptance criteria," but it does not provide the specific quantitative acceptance criteria or the numerical reported device performance values.

1. Table of Acceptance Criteria and Reported Device Performance:

Specific tests conducted include:

• In vitro performance tests: Dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, and particulate evaluation.
• Biocompatibility tests: Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance), pyrogenicity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma).

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the tests.
• Data Provenance: The tests are described as in vitro (laboratory) and biocompatibility tests. No patient data or clinical study data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a physical medical device. "Ground truth" for this device type would be engineering specifications and regulatory standards, not expert interpretations of medical images/data.

4. Adjudication method for the test set:

• Not applicable. (No expert review or diagnostic assessment is described for this device's evaluation.)

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study is for evaluating diagnostic performance of AI or imaging systems involving human readers. This device is a catheter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• For in vitro and biocompatibility tests, the "ground truth" would be established engineering specifications, material standards, and regulatory requirements (e.g., ISO standards, FDA guidance documents like the "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)").

8. The sample size for the training set:

• Not applicable. This is not an AI/Machine Learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. (No training set for an AI model.)

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